Unique Device Identification (UDI) hub

Learn about Australia's Unique Device Identification (UDI) system and the Australian UDI Database (AusUDID).

On this page:

The Australian Unique Device Identification (UDI) system supports accurate medical device identification and forms broader reforms to strengthen medical device regulation.

UDI can:

improve the traceability of medical devices
support the management of safety-related activities
enable faster responses to recalls, safety alerts and adverse events.

Australia's UDI system aligns, where possible, with international approaches to help improve the consistency and quality of device information while reducing regulatory complexity for industry.

The Australian UDI system is being implemented over 5 years, starting with higher-risk devices and progressively extending to lower-risk devices.

Understanding UDI

Learn the fundamentals of UDI, including how the Australian UDI system works, whether it applies to your devices, and your responsibilities.

Purpose and benefits of UDI

Understand how UDI supports patient safety through improved device traceability, faster recalls and enhanced post-market surveillance.
Introduction to UDI requirements

Learn how Australia’s UDI framework aligns globally and fits within the Essential Principles.
Sponsor and manufacturer obligations

Understand the responsibilities of sponsors and manufacturers in meeting UDI requirements.
UDI compliance timeframes

Learn when Unique Device Identification (UDI) requirements become mandatory for medical devices and in vitro diagnostic (IVD) medical devices supplied in Australia.

Meeting UDI requirements

Understand how to comply with UDI requirements, including obtaining a UDI, applying UDI labelling, and meeting requirements for specific device types.

UDI and other device identifiers

Learn about each type of identifier required under the Australian UDI framework.
Getting a UDI

Learn how to obtain a UDI and which internationally issued UDIs are accepted in Australia.
UDI labelling and packaging

Understand and apply the UDI labelling and packaging requirements to your medical devices.
UDI for specific device types

Learn about UDI requirements for specific device types, including implantable medical devices, Software as a Medical Device (SaMD), and surgical loan kits.

Accessing and using the AusUDID

Learn about the Australian UDI Database (AusUDID), including how to access the system, submit UDI records and manage data.

About the AusUDID

Learn what the AusUDID is and how it supports Australia’s UDI system.
Accessing the AusUDID

Understand user roles, responsibilities and how to access the AusUDID.
Submitting and managing UDI records in the AusUDID

Learn about the available submission methods and how to create, maintain and manage UDI records.
AusUDID concepts

Understand key concepts that apply to creating and managing UDI records in the AusUDID.

Maintaining compliance with UDI requirements

Understand your ongoing obligations for maintaining compliance with UDI requirements.

Managing UDI Triggers

Learn which changes to a device are considered a UDI Trigger, and how to manage these changes.
UDI and other TGA processes

Learn how UDI requirements relate to other TGA processes and regulatory activities.
UDI and Consent to Supply

Learn about the streamlined Consent to Supply process for medical devices that do not meet Unique Device Identification (UDI)-related Essential Principles.

Resources and tools

Access guidance documents, templates, technical documentation and practical resources to support compliance with UDI requirements.

UDI guidance documents

Read key guidance to help you understand and meet Australia’s Unique Device Identification (UDI) requirements.
AusUDID technical resources

Access technical documents, templates and release notes.
UDI resources

Access practical resources to support understanding and implementation of UDI requirements.

Engagement and events

Stay informed, participate in consultation activities, and access past engagement materials.

UDI webinars and events

Unique Device Identification (UDI) webinars cover a range of topics including introductory UDI information, adoption in healthcare and software support for UDI.
UDI news and updates

Read the latest news and information related to Unique Device Identification (UDI) in Australia.
Subscribe to UDI updates or request a meeting

Subscribe to UDI updates and request a meeting with the TGA to support your understanding and implementation of UDI requirements.
UDI consultations and forums

Public consultation papers covering various aspects of Unique Device Identification (UDI) implementation.

UDI for healthcare and consumers

Learn how UDI supports healthcare providers, healthcare organisations, patients and consumers.

UDI for healthcare

Understand the benefits of UDI in healthcare and how healthcare organisations can prepare for and adopt UDI.
UDI for consumers

Learn what Unique Device Identification (UDI) means for consumers and patients and how it can improve patient safety.

Product types

Medical devices

Latest articles

New UDI requirements for medical devices commence 1 July 2026

1 July 2026

News articles

From 1 July 2026, some medical devices supplied in Australia must meet Unique Device Identification (UDI) requirements.
Medical device adverse event monitoring update

2 July 2025

News articles

An update about expected increases in the number of medical device incident reports reported to the TGA
New regulations to strengthen medical device patient safety

30 June 2025

Media releases

Australians who rely on medical devices will benefit from new measures introduced by the Australian Government to enhance the identification and management of device-related safety concerns.

Latest publications

Submissions received for proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia

14 August 2019

Corporate reports

Submissions received on the Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia have been published.